BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3629505 · Received February 14, 2014

    Report

    Report Number
    3004209178-2014-03049
    Event Type
    Injury
    Date Received
    February 14, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 24, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_RECHARGER_ACC, PRODUCT TYPE: RECHARGER. PRODUCT ID: NE U_UNKNOWN_LEAD, SERIAL# PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_RECHARGER_ACC, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. PRODUCT ID: N EU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE DEVICE WAS REPLACED AND THE EVENT RESOLVED WITHOUT SEQUELAE (B)(6) 2014. THE DEVICE WAS INTERROGATED AND NOTED AS HAVING AN EMPTY BATTERY. THE ETIOLOGY WAS NOTED AS SUBJECT USABILITY ISSUES. THE PATIENT HAD COGNITIVE DIFFICULTIES WITH RECHARGING. THE EVENT WAS RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING PROBLEMS WITH RECHARGING. IT WAS NOTED THAT THE EVENT RESULTED IN IN-PATIENT HOSPITALIZATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S PARKINSON¿S SYMPTOMS INCREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98410 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization